<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-AMY601CN</udiDi>
    <basicUdiDi>B-AMY601CN</basicUdiDi>
    <tradeName>Amylase Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMY6011Y, AMY6012Y, AMY6013Y, AMY6014Y, AMY6015Y, AMY6011N, AMY6012N, AMY6013N, AMY6014N, AMY6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-anti-dsDNA706-AEST</udiDi>
    <basicUdiDi>B-anti-dsDNA706-AEST</basicUdiDi>
    <tradeName>Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>anti-dsDNA706-AE10Y, anti-dsDNA706-AE10N, anti-dsDNA706-AE20Y, anti-dsDNA706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-TP706-AECQ</udiDi>
    <basicUdiDi>B-Anti-TP706-AECQ</basicUdiDi>
    <tradeName>Anti-TP Treponema Pallidum Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-TP706-AE10Y, Anti-TP706-AE10N, Anti-TP706-AE20Y, Anti-TP706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-anti-tTG706-AEYS</udiDi>
    <basicUdiDi>B-anti-tTG706-AEYS</basicUdiDi>
    <tradeName>Anti-tTG IgG Anti-tissue Transglutaminase IgG Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"anti-tTG706-AE10Y, anti-tTG706-AE10N, anti-tTG706-AE20Y, anti-tTG706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOA1601ED</udiDi>
    <basicUdiDi>B-APOA1601ED</basicUdiDi>
    <tradeName>Apolipoprotein A1 Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOA16011Y, APOA16012Y, APOA16013Y, APOA16014Y, APOA16015Y, APOA16011N, APOA16012N, APOA16013N, APOA16014N, APOA16015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOA2601EL</udiDi>
    <basicUdiDi>B-APOA2601EL</basicUdiDi>
    <tradeName>Apolipoprotein A2 Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOA26011Y, APOA26012Y, APOA26013Y, APOA26014Y, APOA26015Y, APOA26011N, APOA26012N, APOA26013N, APOA26014N, APOA26015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOB601VT</udiDi>
    <basicUdiDi>B-APOB601VT</basicUdiDi>
    <tradeName>Apolipoprotein B Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOB6011Y, APOB6012Y, APOB6013Y, APOB6014Y, APOB6015Y, APOB6011N, APOB6012N, APOB6013N, APOB6014N, APOB6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOC2601FA</udiDi>
    <basicUdiDi>B-APOC2601FA</basicUdiDi>
    <tradeName>Apolipoprotein C2 Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOC26011Y, APOC26012Y, APOC26013Y, APOC26014Y, APOC26015Y, APOC26011N, APOC26012N, APOC26013N, APOC26014N, APOC26015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOE601WG</udiDi>
    <basicUdiDi>B-APOE601WG</basicUdiDi>
    <tradeName>Apolipoprotein E Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOE6011Y, APOE6012Y, APOE6013Y, APOE6014Y, APOE6015Y, APOE6011N, APOE6012N, APOE6013N, APOE6014N, APOE6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ASD706-AET3</udiDi>
    <basicUdiDi>B-ASD706-AET3</basicUdiDi>
    <tradeName>ASD Androstenedione (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD706-AE10Y, ASD706-AE10N, ASD706-AE20Y, ASD706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:54.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ASO601CJ</udiDi>
    <basicUdiDi>B-ASO601CJ</basicUdiDi>
    <tradeName>Antistreptolysin O Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASO6011Y, ASO6012Y, ASO6013Y, ASO6014Y, ASO6015Y, ASO6011N, ASO6012N, ASO6013N, ASO6014N, ASO6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:54.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AST601DM</udiDi>
    <basicUdiDi>B-AST601DM</basicUdiDi>
    <tradeName>Aspartate Aminotransferase Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AST6011Y, AST6012Y, AST6013Y, AST6014Y, AST6015Y, AST6011N, AST6012N, AST6013N, AST6014N, AST6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:54.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATG706-AEV9</udiDi>
    <basicUdiDi>B-ATG706-AEV9</basicUdiDi>
    <tradeName>A-TG Antibody to Thyroglobulin (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATG706-AE10Y, ATG706-AE10N, ATG706-AE20Y, ATG706-AE20Y</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:53.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATPO706-AE79</udiDi>
    <basicUdiDi>B-ATPO706-AE79</basicUdiDi>
    <tradeName>A-TPO Antibody to Thyroid Peroxidase (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATPO706-AE10Y, ATPO706-AE10N, ATPO706-AE20Y, ATPO706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:53.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATSHR706-AEGS</udiDi>
    <basicUdiDi>B-ATSHR706-AEGS</basicUdiDi>
    <tradeName>Anti-TSHR Antibody to Thyroid Stimulating Hormone Receptor (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATSHR706-AE10Y, ATSHR706-AE10N, ATSHR706-AE20Y, ATSHR706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:53.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B2-MG-E06a47</udiDi>
    <basicUdiDi>B-B2-MG-E06a47</basicUdiDi>
    <tradeName>β2-MG Test Kit FIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>β2-MG-E06a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:45.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B2-MG601SS</udiDi>
    <basicUdiDi>B-B2-MG601SS</basicUdiDi>
    <tradeName>β2-Microglobulin Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>β2-MG6011Y, β2-MG6012Y, β2-MG6013Y, β2-MG6014Y, β2-MG6015Y, β2-MG6011N, β2-MG6012N, β2-MG6013N, β2-MG6014N, β2-MG6015N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:45.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BNP-D26aEA</udiDi>
    <basicUdiDi>B-BNP-D26aEA</basicUdiDi>
    <tradeName>BNP Test Kit FIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BNP-D26a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:42.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BNP706-AEX7</udiDi>
    <basicUdiDi>B-BNP706-AEX7</basicUdiDi>
    <tradeName>BNP B-type Natriuretic Peptide (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BNP B-type Natriuretic Peptide (CLIA)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:42.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C-P706-AECW</udiDi>
    <basicUdiDi>B-C-P706-AECW</basicUdiDi>
    <tradeName>C-P C-Peptide (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-P706-AE10Y, C-P706-AE10N, C-P706-AE20Y, C-P706-AE20N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:25.136Z</lastUpdated>
  </row>
</eudamedExport>